AURICAL HIT by GN OTOMETRICS | FDA 510(k) Summary

The Aurical HIT Type 1082 is intended to be used by audiologists, technicians, and other professionals who perform hearing instrument testing. Used in conjunction with the OTOSuite software, the Type 1082 permits presentation of acoustic sounds and magnetic field stimuli in order to assess the audio processing and telecoil functionality of the hearing instrument.

Device Description

AURICAL HIT is designed for Hearing Instrument Testing and Coupler-Based Fitting. AURICAL HIT connects via USB to a computer running the OTOsuite software. With the OTOsuite HIT Module one can perform traditional hearing instrument testing according to either the ANSI or IEC test protocols, and obtain a consistent picture of every hearing instrument, regardless of manufacturer or type. With the OTOsuite PMM Module one can perform Probe Microphone Measurements in a coupler for pre-programming and pre-fitting hearing instruments without the client being present. It is easy to position hearing instruments on snap-on couplers inside the AURICAL HIT test chamber and it is easy to access the hearing instruments in the test chamber during test without disturbing the test setup. The battery pill types are recognized automatically, and the reference microphone ensures reliable positioning in the test chamber.

AI/ML Overview

The document provided describes the Aurical HIT Type 1082, a hearing aid calibrator. The evaluation involved non-clinical performance testing against established standards, rather than studies involving human participants or complex AI algorithms. Therefore, many of the requested categories are not applicable.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (Predicate Device)	Reported Device Performance (Aurical HIT Type 1082)
Intended Use	Hearing Aid Testing	Hearing Aid Testing
Hearing-aid test-box characteristics (C/Tests)	OSPL90, Full on gain, Input/Output, Attack/Recovery time, Reference test gain, Frequency response, Equivalent input noise, Harmonic distortion, Battery current drain, TeleCoil	OSPL90 & HFA-OSPL90, Full on gain, Input/Output, Attack/Recovery time, Reference test gain, Frequency response, Equivalent input noise, Harmonic distortion, Battery current drain, TeleCoil
Test Level Range	50 - 90 dB SPL	40 - 100 dB SPL
Frequency Range	125 Hz - 8 kHz	125 - 10,000 Hz
Standards met for Hearing Instrument Testing	ANSI S3.22, IEC 60118-7	ANSI S3.22: 2003, IEC 60118-7: 2005
Electrical Safety Standard	IEC 60601-1, Class 1, Type B	IEC 61010-1
EMC Standard	IEC 60601-2	IEC 61326-1
Power Supply	USB, and external power supply for elevated outputs	USB Max. 2.5 W
Communication Port	USB 2	USB 2.0
PC Minimum Requirements	CPU Minimum 1.4 GHz, 512MB RAM, 1GB HDD, Windows XP/Vista/7	1.5 GHz or higher CPU (2 GHz recommended), 512 MB RAM (1 GB recommended for XP, 1 GB/1.5 GB recommended for Vista/7), 2.5 GB free disk space, Windows® XP/Vista/7

2. Sample Size Used for the Test Set and Data Provenance:

The document describes "non-clinical performance testing of the device against the applicable parameters specified in the following standards: ANSI S3.22: 2003, and IEC 60118-7:2005." This indicates bench testing of the device's physical and functional characteristics.

Test set sample size: Not applicable in the context of human data. The "sample" here refers to the device itself and its components undergoing tests according to industry standards.
Data provenance: Not applicable. The data is generated from performance testing of the manufactured device in a controlled lab environment according to specified international standards. It is not from a clinical population or geographical region.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The "ground truth" for this device is defined by the objective performance parameters outlined in the referenced ANSI and IEC standards for hearing aid calibrators. There is no mention of expert consensus being used to establish these fundamental technical standards.

4. Adjudication Method for the Test Set:

Not applicable. As the testing involves objective measurement against established technical standards, adjudication by experts is not described or required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. The device is a hearing aid calibrator, a piece of diagnostic equipment, not an AI system designed to assist human "readers" (e.g., radiologists, pathologists). Therefore, MRMC studies are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a hardware device with accompanying software for instrument control and data acquisition, not a standalone algorithm or AI. The performance tested is the device's ability to precisely measure and present acoustic/magnetic stimuli as per the established technical standards.

7. The Type of Ground Truth Used:

The ground truth used is based on technical specifications and performance requirements defined by international standards:

ANSI S3.22: 2003 (American National Standard for Hearing Aid Characteristics)
IEC 60118-7: 2005 (International Electrotechnical Commission standard for Hearing Aids - Part 7: Measurement of the performance characteristics of hearing aids for quality inspection purposes)
IEC 61010-1 (Safety requirements for electrical equipment for measurement, control, and laboratory use)
IEC 61326-1 (Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements)

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/machine learning system that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

510(K) Summary, 510(k) K122028 Submitter: GN Otometrics A/S Hoerskaetten 9 Taastrup, DENMARK DK-2630 Registration number: 9612197 C/O GN Otometrics North America 50 Commerce Dr Ste 180 Schaumburg, IL 60173 (US) Phone: 847-534-2150 (US) Fax: 847-534-2153 Contact: Dan Sansonetti, Manager of Research and Development Date Prepared: October 16, 2012

OCT
2 3
2012

Identification of the Device: 1. Proprietary-Trade Name: Aurical HIT Type 1082 Classification Name: Calibrator, hearing aid / earphone and analysis systems, Class II Common/Usual Name: Hearing aid calibrator
1. Product code: ETW
Equivalent legally marketed devices: 510(K) Number K113831 PRIMUS HEARING 3. INSTRUMENT TEST UNIT, AUDITDATA A/S.
Description of the Device: AURICAL HIT is designed for Hearing Instrument Testing and 4. Coupler-Based Fitting. AURICAL HIT connects via USB to a computer running the OTOsuite software. With the OTOsuite HIT Module one can perform traditional hearing instrument testing according to either the ANSI or IEC test protocols, and obtain a consistent picture of every hearing instrument, regardless of manufacturer or type. With the OTOsuite PMM Module one can perform Probe Microphone Measurements in a coupler for pre-programming and pre-fitting hearing instruments without the client being present. It is easy to position hearing instruments on snap-on couplers inside the AURICAL HIT test chamber and it is easy to access the hearing instruments in the test chamber during test without disturbing the test setup. The battery pill types are recognized automatically, and the reference microphone ensures reliable positioning in the test chamber.
న. Indications for Use (intended use): The Aurical HIT Type 1082 is intended to be used by audiologists, technicians, and other professionals who perform hearing instrument testing. Used in ' conjunction with the OTOSuite software, the Type 1082 permits presentation of acoustic sounds and magnetic field stimuli in order to assess the audio processing and telecoil functionality of the hearing instrument.
Safety and Effectiveness, comparison to predicate device. This device has the same indications 6. for use as the predicate device and employs similar technology to accomplish the same tasks.
1. Description of Testing: Testing consisted of non-clinical performance testing of the device against the applicable parameters specified in the following standards: ANSI S3.22: 2003, and IEC 60118-7:2005 The device passed UL Electrical Safety (IEC 61010-1) testing and EMC (IEC 61326-1) testing. Software validation and risk analysis was performed.

{1}------------------------------------------------

Substantial Equivalence Chart 8.

. . ・・

Characteristic	Auditdata Primus K113831	Aurical HIT Type 1082
Intended Use:	Hearing Aid Testing	Hearing Aid Testing
Hearing-aid test-box characteristics:
C/Tests	OSPL90	OSPL90 & HFA-OSPL90
	Full on gain	Full on gain
	Input/Output	Input/Output
	Attack/Recovery time	Attack/Recovery time
	Reference test gain	Reference test gain
	Frequency response	Frequency response
	Equivalent input noise	Equivalent input noise
	Harmonic distortion	Harmonic distortion
	Battery current drain	Battery current drain
	TeleCoil	TeleCoil
Test Level Range:	50 - 90 dB SPL	40 - 100 dB SPL
Freq. Range	125 Hz - 8 kHz	125 - 10,000 Hz
Standards met for Hearing	ANSI S3.22	ANSI S3.22: 2003
Instrument Testing	IEC 60118-7	IEC 60118-7: 2005
Electrical Safety	IEC 60601-1, Class 1, Type B	IEC 61010-1
EMC	IEC 60601-2	IEC 61326-1
Power supply	USB, and external power supplyfor elevated outputs	USB Max. 2.5 W
Communication port	USB 2	USB 2.0
PC minimum requirements	CPU Minimum 1.4 GHz processorwith 512 MB (1 GB recommended)system RAMHarddisk space 1 GB free harddiskspace for PrimusOperating system Windows XPProfessional SP2 (32-bit), WindowsVista (32-bit) including: Vista HomeBasic, Vista Home Premium, VistaBusiness, Vista Enterprise and VistaUltimate, Windows 7 (32-bit)including Windows 7Home Premium, Windows 7Professional and Windows 7Ultimate Graphics card 1024 x 768.XVGA Connections CD drive andUSB 2.0 connection required	1.5 GHz processor or higher (2 GHzrecommended) • 512 MB RAM (1 GBrecommended) for Windows XP, or 1GB (1.5 GB recommended) forWindows Vista and Windows 7 • 2.5GB free disk space for installation of theOTOsuite software. Additional diskspace is needed for installation ofprerequisites • Windows® XP (32 bit)with SP3 or higher, or Windows Vista(32 bit) with SP2, or Windows 7 (32 or64 bit) • USB port for connectingaccessories, v. 1.1, or 2.0 • DVD or CD-ROM drive • 32 bit color display,1024x768 screen resolution • 32 MBgraphic memory • Windows-compatiblesound card • Supports NOAH 3.5,NOAH 3.5 for ENTs, or higher, forNOAH mode operation.

{2}------------------------------------------------

K122028

Characteristic	Auditdata Primus K113831	Aurical HIT Type 1082
Photo	Image: Auditdata Primus K113831	Image: Aurical HIT Type 1082

1. Conclusion: The Aurical HIT Type 1082 meets applicable standards for hearing instrument testers: ANSI S3.22: 2003 and IEC 60118-7: 2005. Per the bench performance testing, software testing, and safety testing, we conclude that the Aurical HIT Type 1082 is as safe and effective as the predicate device, and has essentially the same indications for use, thus rendering it substantially equivalent to the predicate device.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

GN Otometrics A/S c/o Daniel Kamm. P.E. Regulatory Engineer, Submission Correspondent Kamm & Associates 8870 Ravello Ct. Naples, FL 34114

Re: K122028

Trade/Device Name: Aurical HIT Regulation Number: 21 CFR 874.3310 Regulation Name: Hearing aid calibrator and analysis system Regulatory Class: Class II Product Code: ETW Dated: September 11, 2012 Received: September 21, 2012

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

OCT 2 3 2012

{4}------------------------------------------------

Page 2 - Daniel Kamm. P.E.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Edw. K. Underwood

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

K122028

Indications for Use

510(k) Number (if known): K122028

Device Name: Aurical HIT Type 1082

Indications For Use:

Prescription Use X 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vassil Raich

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K122028

Page 1 of 1

Regulation Number and Section

§ 874.3310 Hearing aid calibrator and analysis system.

(a)
Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.